A Phase 2 Study to Assess STP938 (Dencatistat) as a Monotherapy in Adults With High Risk Essentia… (NCT06786234) | Clinical Trial Compass
RecruitingPhase 2
A Phase 2 Study to Assess STP938 (Dencatistat) as a Monotherapy in Adults With High Risk Essential Thrombocythaemia - The VECTRA Trial
France, United Kingdom50 participantsStarted 2025-06-18
Plain-language summary
The goal of this clinical trial is to learn if the drug STP938 works to treat adults with high risk essential thrombocythaemia (ET) who are resistant to, or intolerant of, hydroxycarbamide (also known as hydroxyurea) therapy. The trial will also learn about the safety of STP938. The main questions the trial aims to answer are:
* Does STP938 control platelet counts
* Does STP938 control platelet counts without inducing unwanted side effects
Participants will:
* Take STP938 every day for up to 12 months.
* Visit the clinic once every week for the first month, then every 2 weeks for checkups and tests.
* Complete a questionnaire about symptoms once a month.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
* Adults aged 18 years or older
* A confirmed diagnosis of ET according to World Health Organisation (WHO) or British Society for Haematology (BSH) criteria.
* Meeting criteria for high risk ET.
* Raised platelet count (\>600 x109/L) requiring cytoreductive therapy.
* Neutrophil count \>1.0 x109/L.
* Either intolerant of or resistant to hydroxycarbamide having met any one of the criteria at any point in their disease whilst receiving hydroxycarbamide.
* Adequate hepatic function.
* Adequate blood coagulation parameters.
* Eastern Cooperative Oncology Group (ECOG) status of 0-2.
Key Exclusion Criteria:
* Subjects currently or recently receiving cytoreductive therapy for the treatment of essential thrombocythaemia (wash out periods apply).
* Subjects who have received any investigational agents for the treatment of essential thrombocythaemia within 4 weeks before enrolment or less than 5 half-lives since completion of prior therapy, whichever is shorter.
* Proven or suspected transformation to polycythaemia vera, myelofibrosis, myelodysplasia, acute myeloid leukaemia or another myeloid neoplasm.
* Known malabsorption syndrome or other condition that may impair absorption of study medication (e.g. gastrectomy).
* Previous splenectomy.
* Any uncontrolled intercurrent illness.
* Immunocompromised subjects with increased risk of opportunistic infections.
* Known active or chronic hepatitis B or active hepatitis C virus (HCV) infection.
* Pregnant females,…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical Efficacy
Timeframe: Through study completion, an average of 12 months
2
Safety and Tolerability
Timeframe: Through study completion, an average of 12 months